Abstract
Background and Aims
The aim of this study was to evaluate the efficacy and safety of glargine U300 in patients with type 2 diabetes (DM2) recently switched from NPH insulin in real-life settings
Methods
We conducted a national, observational, multicenter, prospective, 24-weeks product registry. The primary endpoint was percentage of patients reaching HbA1c reduction of 0.5% or more at the end of the study (EOS); the secondary endpoints were: FPG and HbA1c level at EOS and change from baseline, number of of participants, who experienced ≥1 episode of symptomatic nocturnal hypoglycemia.
Results
Among 469 analyzed patients, the primary endpoint was achieved by 71.7% of patients. HbA1c decreased by 1.02 ± 1.11 % (p<0.0000 vs. baseline) from 9.19 ± 1.11 % at baseline to 8.17 ± 1.17 % at EOS. Average FPG decreased by 37.1 ± 44.5 mg/dL (p<0.0000 vs. baseline) from 178.0 ± 46.0 mg/dL to 140.9 ± 40.7 mg/dL at EOS. The number of participants, who experienced ≥1 episode of symptomatic nocturnal hypoglycemia decreased significantly from 76 (66.1%) at baseline to 9 (14.8%) after 24 weeks of observation (p<0.0000). Average annual rate of symptomatic nocturnal hypoglycemia episodes was 0.33. None of the patients had severe hypoglycemia after switching to glargine U300 throughout whole observation period. The body weight did not change significantly.
Conclusions
It has been shown that people with uncontrolled T2D treated with NPH that switching to Gla-300 significantly improved their glycemic control while significantly decreasing the number of both symptomatic and nocturnal hypoglycemia events